Attention Deficit Hyperactivity DisorderPhase 3NCT02520388
A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Naturalistic Setting
A Phase 3 study testing HLD200 methylphenidate hydrochloride (MPH) Capsules in people with Attention Deficit Hyperactivity Disorder, run by Ironshore Pharmaceuticals and Development, Inc at 21 sites in United States.
Trial summary
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of 3 weeks (Visits 2-5) before assessing… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- HLD200 methylphenidate hydrochloride (MPH) Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 21 sitesUnited States
- Study dates
- Aug 2015to May 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must be male or female children (6 to 12 years at the time of consent).
- Subjects must have a diagnosis of ADHD as defined by DSM5 criteria and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Subjects must have a baseline ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in total score. In addition, this ADHD-RS-IV total score must be ≥26 at Baseline.
- Subjects must have a Clinical Global Impression of Severity (CGI-S) score ≥4 and a CGI-P score >10 at the Baseline Visit.
- Subjects have demonstrated, in the judgment of the investigator, at least a partial clinical response to MPH.
- Parental or legal guardian confirmation of the child's before-school functional impairment and/or difficulties performing a morning routine of at least 30 minutes minimum duration occurring between 6:00 and 9:00 am.
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- Subject body weight must be ≥20 kg.
- Subject must be considered clinically appropriate for treatment with MPH and HLD200, including ability to swallow treatment capsules.
- Subject must be in general good health based upon the medical history, physical, and laboratory examinations (including urine drug screen).
- Subject and parent or legal guardian must be able to read, write, and/or understand at a level sufficient to provide informed consent (parent/legal guardian) and assent (subject) prior to study participation and to complete study-related materials. Subject and parent or legal guardian must plan to be available for the entire study period.
- Female subjects of childbearing potential (i.e., post-menarche) are required to have a negative result on urine pregnancy testing at screening (and will be given specific instructions for avoiding pregnancy during the study).
- A medically highly effective form of birth control must be used during the study and for 90 days thereafter for subjects of either sex of childbearing potential. Examples of medically highly effective forms of birth control are as follows:
- No sexual activity
- Use of acceptable methods of birth control including intra-uterine device, oral, implantable,or injectable contraceptives.
Who cannot join
- History of, or current, medical condition or laboratory result which, in the opinion of the investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study-related procedures.
- Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- History of seizure disorder (except febrile seizures prior to age 5 and with last occurrence at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM5 criteria).
- History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigator's opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures.
- Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS.
- History of severe allergic reaction or intolerance to MPH.
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- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or creatinine greater than 1.5x the upper limit of normal. Elevated bilirubin due only to Gilbert's syndrome is not exclusionary.
- History of alcohol abuse or illicit drug use.
- Use of prescription medications (except per protocol allowed medications) within 7 days of Baseline (Visit 2), except for ADHD stimulant medication (72 hours) and monoamine oxidase inhibitors (MAOIs) (14 days), and over-the-counter medications (except birth control and allowed medications) within the 3 days preceding Baseline (Visit 2). Medications not covered in allowed medications or prohibited medications must be cleared by the medical monitor prior to enrolling the subject.
- Use of psychotropic medications including antidepressants, mood stabilizers, and antipsychotics.
- Participation in a clinical trial with an investigational drug within the 30 days preceding study enrollment.
- Previous treatment experience with HLD200.
- Positive screening for illicit drug use or nicotine and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject.
- In the opinion of the investigator, the subject may have problems complying with the protocol or the procedures of the protocol, or for which the study could pose unnecessary safety risks. This includes current health conditions or use of medications that might confound the results of the study or increase risk to the subject.
- A sibling or step-sibling that is concurrently participating in this study who resides with and is cared for by the same parent/legal guardian as the subject.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201
Ericksen Research and Development
Clinton, Utah, 84015
Duke University Medical Center, Duke Child and Family Study Center
Durham, North Carolina, 27705
Sarkis Clinical Trials
Gainesville, Florida, 32607
Bayou City Research, Ltd
Houston, Texas, 77007
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
Westex Clinical Investigations
Lubbock, Texas, 79423
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
AVIDA
Newport Beach, California, 92660
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
IPS Research Company
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Medical Research Group of Central Florida
Orange City, Florida, 32763
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Pedia Research, LLC
Owensboro, Kentucky, 42301
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Seattle Children's Hospital
Seattle, Washington, 98105
QPS MRA, dba Miami Research Associates, LLC
South Miami, Florida, 33143
Children's Developmental Center, P.A.
Winter Park, Florida, 32792
About this study
Official title: Ph 3 Multicenter DBRCT Parallel Group Study to Evaluate Safety & Efficacy of Evening-dosed HLD200, a Novel Delayed & Extended Release Formulation (DELEXIS) of MPH HCl, on Post-waking, Early Morning Function in Children Aged 6-12 With ADHD
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of 3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.
Read the detailed description
To address the unmet need for early morning ADHD symptom control, Ironshore has developed a novel drug delivery system that incorporates the active ingredient methylphenidate HCl in a delayed/extended release formulation. This formulation provides a controlled, approximately 8-hour delay in initial drug release, followed by a subsequent controlled rate of drug release throughout the day. The goal of this system is to enable nighttime dosing of methylphenidate to provide control of ADHD symptoms at the beginning of the next morning (immediately upon awakening) and throughout the remainder of the day.
At Visit 2, Baseline Visit), subjects were randomized to receive either HLD200 or placebo and instructed to begin dosing at 40 mg each evening (8:00 pm ±30 minutes) for 1 week, with scheduled titration, as medically indicated and tolerated, over the subsequent 2 weeks to 60 mg (Visit 3) and 80 mg (Visit 4) and/or a dose not to exceed 3.7 mg/kg (based on the subject's most recently assessed weight). Following dose escalation above 40 mg (i.e., after Visit 3), subjects were permitted to reduce the dose by 1 step (i.e., from 60 to 40 mg or from 80 to 60 mg), if necessary, for safety or tolerability. Subjects who were unable to tolerate a dose of at least 40 mg during the final (third) week of treatment, from Visit 4 to 5, were discontinued. Subjects were also permitted to adjust the timing of the evening dosing at Visits 3 and 4 in increments of 30 to 60 minutes/week to achieve optimal morning control of observed ADHD symptoms; however, the dose was not to be taken any later than 9:30 pm or any earlier than 6:30 pm, regardless of the ±30-minute dosing window.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- HLD200 methylphenidate hydrochloride (MPH) Capsules, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLD200 methylphenidate hydrochloride (MPH) CapsulesDrug
Also called methylphenidate
HLD200 Doses: 40, 60 or 80 mg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| HLD200 (methylphenidate) | Experimental | Experimental: HLD200 (methylphenidate)
The investigational drug for this study is HLD200 MPH MR capsules comprised of the active pharmaceutical ingredient (MPH) in a dual-coated drug-layered core. Following a minimum 72-hour washout, subjects will be randomized (1:1) to double-blind HLD200 to be taken once daily during the evening for a period of 3-weeks prior to testing. Receives: Drug: HLD200 methylphenidate hydrochloride (MPH) Capsules |
| Placebo | Placebo comparator | Placebo capsules will be composed of microcrystalline cellulose beads in place of MPH containing beads found in the HLD200 capsules. Following a minimum 72-hour washout, subjects will be randomized (1:1) to double-blind placebo to be taken once daily during the evening for a period of 3-weeks prior to testing. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score.
The ADHD-RS-IV was developed to measure the behaviors of children with ADHD (DuPaul et al., 1998). The scale consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored in a range from 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of almost always), with a range of total scores ranging from 0 to 54. In this study, a site clinican (required to be an MD, PhD, DO, licensed social worker, or any trained mental health professional approved by the sponsor) completed ADHD-RS-IV assessments at each visit using a structured interview format.
Measured: Last week of 3-week treatment period assessed at Visit 5.
Secondary outcomes (1)
Before School Functioning Questionnaire (BSFQ) Total Score
The BSFQ was developed as a hybrid measure completed by a clinician or parent/legal guardian to assess commonly reported areas of morning dysfunction - both behaviors and functions associated with the post-waking, early morning period (from approximately 6:00 am to 9:00 am) - in children and adolescents with ADHD (Wilens et al., 2010; Wilens et al., 2013). Symptom severity and functional impairment were rated from 0 (none) to 3 (severe - different from peers all days, all settings) with total scores ranging from 0 to 60. Ratings were completed by a site clinician (MD, PhD, DO, licensed social worker, or trained mental health professional approved by the sponsor) at Visits 2 through 5 using a structured interview format.
Measured: Last week of 3-week treatment period assessed at Visit 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironshore Pharmaceuticals and Development, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Newcorn Jeffrey, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520388
- Sponsor's protocol ID
- HLD200-108
- Status last verified
- Jul 2021
- First submitted
- 7 Aug 2015
- Last updated
- 23 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.
PubMed 41342306Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
PubMed 36971690Wilens TE, Faraone SV, Hammerness PG, Pliszka SR, Uchida CL, DeSousa NJ, Sallee FR, Incledon B, Newcorn JH. Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate. J Atten Disord. 2022 Mar;26(5):696-705. doi: 10.1177/10870547211020073. Epub 2021 Jun 4.
PubMed 34085581Lopez FA, Faraone SV, Newcorn JH, Doll HA, Rhoten S, Lewis HB, Khan TF, DeSousa NJ, Sallee FR, Incledon B. Effect of Delayed-Release and Extended-Release Methylphenidate on Caregiver Strain and Validation of Psychometric Properties of the Caregiver Strain Questionnaire: Results from a Phase 3 Trial in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Apr;31(3):179-186. doi: 10.1089/cap.2020.0159. Epub 2021 Apr 1.
PubMed 33797983
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph 3 Multicenter DBRCT Parallel Group Study to Evaluate Safety & Efficacy of Evening-dosed HLD200, a Novel Delayed & Extended Release Formulation (DELEXIS) of MPH HCl, on Post-waking, Early Morning Function in Children Aged 6-12 With ADHD
- ClinicalTrials.gov ID
- NCT02520388
- Acronym / sponsor ID
- HLD200-108
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Ironshore Pharmaceuticals and Development, IncUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Posted 3 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of 3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.
Detailed description
To address the unmet need for early morning ADHD symptom control, Ironshore has developed a novel drug delivery system that incorporates the active ingredient methylphenidate HCl in a delayed/extended release formulation. This formulation provides a controlled, approximately 8-hour delay in initial drug release, followed by a subsequent controlled rate of drug release throughout the day. The goal of this system is to enable nighttime dosing of methylphenidate to provide control of ADHD symptoms at the beginning of the next morning (immediately upon awakening) and throughout the remainder of the day.
At Visit 2, Baseline Visit), subjects were randomized to receive either HLD200 or placebo and instructed to begin dosing at 40 mg each evening (8:00 pm ±30 minutes) for 1 week, with scheduled titration, as medically indicated and tolerated, over the subsequent 2 weeks to 60 mg (Visit 3) and 80 mg (Visit 4) and/or a dose not to exceed 3.7 mg/kg (based on the subject's most recently assessed weight). Following dose escalation above 40 mg (i.e., after Visit 3), subjects were permitted to reduce the dose by 1 step (i.e., from 60 to 40 mg or from 80 to 60 mg), if necessary, for safety or tolerability. Subjects who were unable to tolerate a dose of at least 40 mg during the final (third) week of treatment, from Visit 4 to 5, were discontinued. Subjects were also permitted to adjust the timing of the evening dosing at Visits 3 and 4 in increments of 30 to 60 minutes/week to achieve optimal morning control of observed ADHD symptoms; however, the dose was not to be taken any later than 9:30 pm or any earlier than 6:30 pm, regardless of the ±30-minute dosing window.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLD200 (methylphenidate) | Experimental | Drug: HLD200 methylphenidate hydrochloride (MPH) CapsulesExperimental: HLD200 (methylphenidate) The investigational drug for this study is HLD200 MPH MR capsules comprised of the active pharmaceutical ingredient (MPH) in a dual-coated drug-layered core. Following a minimum 72-hour washout, subjects will be randomized (1:1) to double-blind HLD200 to be taken once daily during the evening for a period of 3-weeks prior to testing. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules will be composed of microcrystalline cellulose beads in place of MPH containing beads found in the HLD200 capsules. Following a minimum 72-hour washout, subjects will be randomized (1:1) to double-blind placebo to be taken once daily during the evening for a period of 3-weeks prior to testing. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Subjects must be male or female children (6 to 12 years at the time of consent).
- Subjects must have a diagnosis of ADHD as defined by DSM5 criteria and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Subjects must have a baseline ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in total score. In addition, this ADHD-RS-IV total score must be ≥26 at Baseline.
- Subjects must have a Clinical Global Impression of Severity (CGI-S) score ≥4 and a CGI-P score >10 at the Baseline Visit.
- Subjects have demonstrated, in the judgment of the investigator, at least a partial clinical response to MPH.
Key exclusion criteria (15 listed)
- History of, or current, medical condition or laboratory result which, in the opinion of the investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study-related procedures.
- Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- History of seizure disorder (except febrile seizures prior to age 5 and with last occurrence at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM5 criteria).
- History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigator's opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures.
- Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLD200 methylphenidate hydrochloride (MPH) CapsulesAlso: methylphenidateHLD200 Doses: 40, 60 or 80 mg | Drug | HLD200 (methylphenidate) |
| Placebo | Drug | Placebo |
Primary outcome
Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score.
Time frame: Last week of 3-week treatment period assessed at Visit 5.
The ADHD-RS-IV was developed to measure the behaviors of children with ADHD (DuPaul et al., 1998). The scale consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored in a range from 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of almost always), with a range of total scores ranging from 0 to 54. In this study, a site clinican (required to be an MD, PhD, DO, licensed social worker, or any trained mental health professional approved by the sponsor) completed ADHD-RS-IV assessments at each visit using a structured interview format.
1 secondary outcome
Before School Functioning Questionnaire (BSFQ) Total Score
Time frame: Last week of 3-week treatment period assessed at Visit 5.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41342306Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.
- Derived from this study: PubMed 36971690Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
- Derived from this study: PubMed 34085581Wilens TE, Faraone SV, Hammerness PG, Pliszka SR, Uchida CL, DeSousa NJ, Sallee FR, Incledon B, Newcorn JH. Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate. J Atten Disord. 2022 Mar;26(5):696-705. doi: 10.1177/10870547211020073. Epub 2021 Jun 4.
- Derived from this study: PubMed 33797983Lopez FA, Faraone SV, Newcorn JH, Doll HA, Rhoten S, Lewis HB, Khan TF, DeSousa NJ, Sallee FR, Incledon B. Effect of Delayed-Release and Extended-Release Methylphenidate on Caregiver Strain and Validation of Psychometric Properties of the Caregiver Strain Questionnaire: Results from a Phase 3 Trial in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Apr;31(3):179-186. doi: 10.1089/cap.2020.0159. Epub 2021 Apr 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Newcorn Jeffrey, MD principal investigator
Icahn School of Medicine at Mount Sinai
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HLD200 methylphenidate hydrochloride (MPH) Capsules in people with Attention Deficit Hyperactivity Disorder, run by Ironshore Pharmaceuticals and Development, Inc at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score. (time frame: Last week of 3-week treatment period assessed at Visit 5.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02520388, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.